EDOXABAN for Chronic thromboembolic pulmonary hypertension (CTEPH)|Chronic thromboembolic disease (CTED) without pulmonary hypertension

Inclusion criteria

• {"criterion_text":"-Established CTEPH or CTED diagnosis according to the guideline, with at least 3 months of anticoagulation treatment."}
• {"criterion_text":"-Inoperable patients, patients reluctant to undergo surgery or patients with residual PH after PEA and accepted for BPA treatment."}
• {"criterion_text":"-Accessible thromboembolic lesions for BPA."}

Exclusion criteria

• {"criterion_text":"-Operable CTEPH or CTED patients accepted for PEA."}
• {"criterion_text":"-Contra-indications for BPA: right-sided mechanical heart valve, thrombus or myxoma in the right atrium or right-sided valvular endocarditis."}
• {"criterion_text":"-Contra-indications for DOAC treatment: e.g. mechanical heart valves, myocardial thrombus, triple positive antiphospholipid syndrome, morbid obesity and (status after) bariatric treatment or major gastrointestinal resections and combination with CYP3A4 inhibitors and inductors. Anticoagulation dosage should be adjusted depending on renal function and drug interaction."}
• {"criterion_text":"-High risk patients for bleeding complications: previous life-threatening bleeding (e.g. intracranial bleeding), age >80 years or pulmonary vascular resistance > 10 woods units (WU)."}
• {"criterion_text":"-Life-expectancy <1 year."}

Primary endpoints

• {"endpoint_text":"-Combination of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) based on the international criteria (PH-symposium, VARC and BARC [2-3 and 5]) or lung injury (radiographic opacity with/without haemoptysis, with/without hypoxaemia) within 24 hours after BPA, on a per-session basis.","definition_or_measurement_approach":"Measured on a per-session basis within 24 hours after BPA; bleeding assessed using international criteria (PH-symposium, VARC and BARC [2-3 and 5]); lung injury defined as radiographic opacity with/without haemoptysis, with/without hypoxaemia."}

Secondary endpoints

• {"endpoint_text":"-Individual items of the combined primary endpoint (on a per-session basis).","definition_or_measurement_approach":"Assessed on a per-session basis; individual components of the composite primary endpoint."}
• {"endpoint_text":"-Procedure related endpoints (on a per-session basis): 1) Allergic reaction to contrast (assessed for total complication rate, not for VKA vs DOAC). 2) Renal dysfunction","definition_or_measurement_approach":"Assessed on a per-session basis; allergic reaction to contrast assessed for total complication rate (not for VKA vs DOAC); renal dysfunction recorded as procedure-related endpoint."}
• {"endpoint_text":"-Venous thromboembolism.","definition_or_measurement_approach":"Occurrence of venous thromboembolism events (method of ascertainment not specified in record)."}
• {"endpoint_text":"-Long-term bleeding complications based on international criteria.","definition_or_measurement_approach":"Assessed using international bleeding criteria."}
• {"endpoint_text":"-All-cause mortality.","definition_or_measurement_approach":"Death from any cause."}
• {"endpoint_text":"-Non-scheduled hospitalization.","definition_or_measurement_approach":"Recording of unscheduled hospital admissions."}

Netherlands

Earliest CTIS Part Ii Submission Date

01-11-2024

Latest Decision Or Authorization Date

15-11-2024

Processing Time Days

14

Number Of Sites

2

Number Of Participants

84

Primary sponsor

Full Name

St. Antonius Ziekenhuis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands